NCT00611169

Brief Summary

The purpose of this study to investigate whether the administration of high-dose tirofiban before primary PCI could reduce myocardial infarct size, using analysis of contrast-enhanced magnetic resonance imaging.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
Last Updated

February 8, 2008

Status Verified

August 1, 2007

Enrollment Period

1.1 years

First QC Date

January 27, 2008

Last Update Submit

February 7, 2008

Conditions

Acute Myocardial Infarction

Keywords

Angioplasty, Transluminal, Percutaneous CoronarytirofibanMagnetic Resonance ImagingMyocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Infarct size and its transmural extent using MRI

    within the first 30 days after index procedure

Secondary Outcomes (1)

  • pre-PCI thrombolysis in myocardial infarction grade, post-PCI myocardial blush grade, ST-segment resolution on electrocardiography, and left ventricular ejection fraction on echocardiography

    at 6 month after index procedure

Study Arms (2)

1

EXPERIMENTAL

Aspirin, clopidogrel, unfractionated heparin plus tirofiban infusion at high bolus dose

Drug: tirofiban

2

NO INTERVENTION

Aspirin, clopidogrel, unfractionated heparin

Interventions

tirofibanDRUG

tirofiban (25 μg/kg bolus and 0.15 μg/kg/min maintenance infusion for 24 hours)

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
  • ST-segment elevation more than 1 mm in two or more contiguous leads or presumably a new-onset left bundle branch blockage

You may not qualify if:

  • hemodynamic instability
  • history of MI
  • old age \> 80years
  • Patients with bleeding diathesis (coagulopathy, thrombocytopenia or platelet dysfunction, Gastrointestinal or genitourinary bleeding within the prior 3 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Tirofiban

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

TyrosineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Hyeon-Cheol Gwon, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 27, 2008

First Posted

February 8, 2008

Study Start

January 1, 2006

Primary Completion

February 1, 2007

Study Completion

August 1, 2007

Last Updated

February 8, 2008

Record last verified: 2007-08